転移性去勢抵抗性前立腺癌の中国人参加者におけるアンドロゲン受容体（AR）拮抗薬アパルタミドの研究
転移性去勢抵抗性前立腺癌の中国人被験者におけるアンドロゲン受容体（AR）拮抗薬アパルタミドの第1相研究
The purpose of this study is to evaluate pharmacokinetics (PK) following a single dose and multiple dose treatment and the safety of apalutamide in Chinese participants with metastatic castration resistant prostate cancer (mCRPC) at dose of 240 milligram (mg).
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
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Beijing、中国、100083
- Peking University Third Hospital
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Beijing、中国、100142
- Beijing Cancer Hospital of Peking University
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Nanjing、中国、210000
- Jiangsu Cancer Hospital
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Shanghai、中国、200032
- Fudan Cancer Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (<=) 2
- Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features
- Metastatic disease as documented by bone scan or metastatic lesions by computed tomography or magnetic resonance imaging scans (visceral or lymph node disease). Lymph nodes in the pelvis must measure at least 1.5 centimeter in a short axis to be considered target lesion according to the modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 based on the Prostate Cancer Working Group 2 (PCWG2) criteria
- Castration-resistant prostate cancer (PC) demonstrated during continuous androgen deprivation therapy (ADT), defined as 3 rises of prostate-specific antigen (PSA), at least 1 week apart, with the last PSA greater than or equal to (>=) 2 nanogram per milliliter (ng/mL)
- Prior hormonal interventions (including 1st generation antiandrogens [flutamide, bicalutamide, nilutamide], steroids, estrogens, finasteride, dutasteride) for PC are allowed. These therapies, except for gonadotropin releasing hormone analogs (GnRH) analogs and prednisone/prednisolone, must have been discontinued for minimally 4 weeks (2 weeks only for flutamide, nilutamide, or finasteride) before first dose of study drug
Exclusion Criteria:
- Known brain metastases
- Chemotherapy, or immunotherapy within 2 weeks or 5 half-lives of the drug prior to the first dose of study drug, whichever is longer, with a maximum of 4 weeks.
- Prior treatment with second-generation anti-androgens (example [eg], enzalutamide)
- Administration of an investigational therapeutic within 2 weeks or 5 half-lives of the drug prior to the first dose of study drug, whichever is longer, with a maximum of 4 weeks. And participant use radiopharmaceutical agents (eg, strontium-89) or investigational immunotherapy (eg, sipuleucel-T) within 12 weeks prior to the first dose of study drug
- Prior treatment with cytochrome 17 inhibitors (eg, abiraterone acetate, orteronel, galeterone, systemic ketoconazole)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：Apalutamide
Participants will receive a single oral dose of apalutamide 240 milligram (mg) during pharmacokinetics (PK) Week Day 1 and will be monitored for one week (that is; PK Week) to assess PK and safety of drug. Subsequently, participants will further receive daily treatment of apalutamide from Cycle 1 Day 1 onwards until disease progression, withdrawal of consent, lost to follow-up, or the occurrence of unacceptable toxicity. Each treatment cycle consists of 28 days. After final analysis (FA), participants who are receiving apalutamide in the open-label treatment phase may continue receiving single oral dose apalutamide 240 mg once daily in a long-term extension (LTE) phase if they continue to derive benefit from treatment (based on investigator assessment). |
The participants will receive apalutamide 240 mg once daily orally.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Plasma Concentration of Apalutamide
時間枠：Predose; postdose up to 168 hours (hrs) (Cycle1 Day 7), Cycle 2 (pre-dose; on Day 1 and 15 of cycle 2) and Cycle 3 (pre-dose; up to 24 hrs post-dose). Each cycle is of 28 days
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Plasma concentration of apalutamide will be reported. |
Predose; postdose up to 168 hours (hrs) (Cycle1 Day 7), Cycle 2 (pre-dose; on Day 1 and 15 of cycle 2) and Cycle 3 (pre-dose; up to 24 hrs post-dose). Each cycle is of 28 days
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Number of Participants with Adverse Events
時間枠：Up to 30 days of last study treatment (approximately 18 months)
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An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. |
Up to 30 days of last study treatment (approximately 18 months)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Change from Baseline in Serum Prostate Specific Antigen (PSA) at Weeks 4 and 12
時間枠：Baseline, at Weeks 4 and 12 or earlier for those who discontinue therapy (up to approximately 4 months).
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Change from baseline in serum PSA levels will be determined. |
Baseline, at Weeks 4 and 12 or earlier for those who discontinue therapy (up to approximately 4 months).
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Maximal Decline in Prostate Specific Antigen
時間枠：Up to 30 days of last study treatment (approximately 18 months)
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Maximal decline in PSA levels will be determined. |
Up to 30 days of last study treatment (approximately 18 months)
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協力者と研究者
捜査官
- スタディディレクター：Janssen Research & Development, LLC Clinical Trial、Janssen Research & Development, LLC
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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